[Federal Register Volume 86, Number 136 (Tuesday, July 20, 2021)]
[Rules and Regulations]
[Pages 38230-38232]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-15323]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1305

[Docket No. DEA-662]
RIN 1117-AB61


Clarification Regarding the Supplier's DEA Registration Number on 
the Single-Sheet DEA Form 222

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Direct final rule.

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SUMMARY: The Drug Enforcement Administration (DEA) is issuing this 
direct final rule to amend DEA regulations to clarify that either the 
purchaser or the supplier may enter a supplier's DEA registration 
number on the Single-Sheet DEA Form 222.

DATES: This direct final rule is effective on October 18, 2021 without 
further action, unless significant adverse comment is received by 
August 19, 2021. If the Drug Enforcement Administration (DEA) receives 
significant adverse comment, it will publish a withdrawal of the rule 
in the Federal Register by September 20, 2021. Electronic comments must 
be submitted, and written comments must be postmarked, on or before 
August 19, 2021. Commenters should be aware that the electronic Federal 
Docket Management System will not accept comments after 11:59 p.m. 
Eastern Time on the last day of the comment period.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-662'' on all correspondence, including any 
attachments.
    Electronic comments: DEA encourages that all comments be submitted 
through the Federal eRulemaking Portal, which provides the ability to 
type short comments directly into the comment field on the web page or 
attach a file for lengthier comments. Please go to http://www.regulations.gov and follow the online instructions at that site for 
submitting comments. Upon completion of your submission, you will 
receive a Comment Tracking Number for your comment. Please be aware 
that submitted comments are not instantaneously available for public 
view on Regulations.gov. If you have received a Comment Tracking 
Number, your comment has been successfully submitted and there is no 
need to resubmit the same comment.
    Paper comments: Paper comments that duplicate an electronic 
submission are not necessary and are discouraged. Should you wish to 
mail a paper comment in lieu of an electronic comment, it should be 
sent via regular or express mail to: Drug Enforcement Administration, 
Attention: DEA Federal Register Representative/DPW, 8701 Morrissette 
Drive, Springfield, Virginia 22152.

FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, Regulatory Drafting 
and Policy Support Section, Diversion Control Division, Drug 
Enforcement Administration; Telephone: (571) 776-2265.

SUPPLEMENTARY INFORMATION:

Posting of Public Comments

    Please note that all comments received are considered part of the 
public record. They will, unless reasonable cause is given, be made 
available by the Drug Enforcement Administration (DEA) for public 
inspection online at http://www.regulations.gov. Such information 
includes personal identifying information (such as your name, address, 
etc.) voluntarily submitted by the commenter. The Freedom of 
Information Act applies to all comments received. If you want to submit 
personal identifying information (such as your name, address, etc.) as 
part of your comment, but do not want it to be made publicly available, 
you must include the phrase ``PERSONAL IDENTIFYING INFORMATION'' in the 
first paragraph of your comment. You must also place all of the 
personal identifying information you do not want publicly available in 
the first paragraph of your comment and identify what information you 
want redacted.
    If you want to submit confidential business information as part of 
your comment, but do not want it to be made publicly available, you 
must include the phrase ``Confidential Business Information'' in the 
first paragraph of your comment. You must also prominently identify 
confidential business information to be redacted within the comment.
    Comments containing personal identifying information and 
confidential business information as directed above will generally be 
made publicly available in redacted form. If a comment has so much 
confidential business information or personal identifying information 
that it cannot be effectively redacted, all or part of that comment may 
not be made publicly available. Comments posted to http://www.regulations.gov may include any personal identifying information 
(such as name, address, and phone number) included in the text of your 
electronic submission that is not identified as directed above as 
confidential.
    An electronic copy of this direct final rule is available at http://www.regulations.gov under FDMS Docket ID: DEA-2020-0036.

Legal Authority and Background

    The Controlled Substances Act (CSA) grants the Attorney General 
authority to promulgate rules and regulations relating to the 
registration and control of the manufacture, distribution, and 
dispensing of controlled substances; maintenance and submission of 
records and reports; and for the efficient execution of his statutory 
functions.\1\ The CSA further authorizes the Attorney General to 
promulgate rules and regulations relating to the registration and 
control of importers and exporters of controlled substances.\2\ The 
Attorney General has delegated this authority to the Administrator of 
DEA.\3\
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    \1\ 21 U.S.C. 821, 827, 871(b).
    \2\ 21 U.S.C. 958(f).
    \3\ 28 CFR 0.100(b).
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    The DEA Form 222 is used by DEA registrants to order schedule I and 
II controlled substances. In September 2019, DEA issued a final rule to 
implement a new single-sheet DEA Form 222 (single-sheet form) to 
replace the three-part carbon copy form (triplicate form), and allowed 
a transition period for use of existing stocks of the triplicate form 
until October 30, 2021 (or earlier if the registrant exhausts its 
supply).\4\ Both the single-sheet and triplicate forms require certain 
information to be completed

[[Page 38231]]

pertaining to the supplier (i.e., supplier name, address, and DEA 
registration number). The final rule set forth a procedure for the 
supplier filling DEA Forms 222 and providing its DEA registration 
number, among other things, and specifically provides that ``[a] 
supplier may fill the order . . . and must record on the original DEA 
Form 222 its DEA registration number.'' \5\
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    \4\ New Single-Sheet Format for U.S. Official Order Form for 
Schedule I and II Controlled Substances (DEA Form 222) 84 FR 51368, 
Sept. 30, 2019.
    \5\ 21 CFR 1305.13(b).
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    As previously noted, both the single-sheet and triplicate forms 
require the supplier's DEA registration number to be recorded. On the 
triplicate form, the field for the supplier's DEA registration number 
is located within a section titled ``TO BE FILLED IN BY SUPPLIER.'' 
However, on the single-sheet form, the field for the supplier's DEA 
registration number is located directly above a section titled ``TO BE 
FILLED IN BY PURCHASER.'' This has led to some confusion regarding who 
must record the supplier's DEA registration number on the single-sheet 
DEA Form 222.

Clarification on Completing the Supplier's DEA Registration Number 
Information

    Since the publication of the single-sheet final rule, DEA has 
received inquiries regarding whether the purchaser or the supplier 
should enter the supplier's DEA registration number on the single-sheet 
form. DEA is amending its regulations to clarify that either the 
purchaser or the supplier may fill in this information. DEA also notes 
that the single-sheet form has been slightly modified--and approved by 
the Office of Management and Budget (OMB) in July 2020--by the addition 
of a line that separates the field for the supplier's DEA registration 
number from the field titled, ``PART 2: TO BE FILLED IN BY PURCHASER,'' 
in which the supplier's business name and address are recorded. This 
revised version of the form is being provided to any registrant 
requesting paper DEA Forms 222 pursuant to 21 CFR 1305.11.

Regulatory Analyses

Administrative Procedure Act

    An agency may find good cause to exempt a rule from prior public 
notice provisions of the Administrative Procedure Act (APA) (5 U.S.C. 
553(b)(B)), if it is determined to be unnecessary, impracticable, or 
contrary to the public interest. This rule clarifies that either the 
purchaser or supplier may enter the supplier's DEA registration number 
on the single-sheet DEA Form 222. Furthermore, DEA notes that this rule 
does not impose any new requirements as the supplier's DEA registration 
number is already required to be entered on the single-sheet form.\6\ 
Therefore, DEA concludes it is unnecessary to issue this rule for 
public notice and comment, prior to issuing a final rule, and finds 
good cause to exempt this rule from the provisions of the APA under 5 
U.S.C. 553(b)(B). For the same reasons, DEA has determined that this 
rule is suitable for direct final rulemaking. Although DEA does not 
expect to receive significant adverse comment on this rule, DEA has 
decided to allow for public comment. If DEA receives significant 
adverse comment within 30 days of the publication of this final rule, 
it will publish a timely withdrawal of the rule in the Federal 
Register.
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    \6\ 21 CFR 1305.13(b).
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Executive Orders 12866 (Regulatory Planning and Review) and 13563 
(Improving Regulation and Regulatory Review)

    This direct final rule was developed in accordance with the 
principles of Executive Orders (E.O.) 12866 and 13563. E.O. 12866 
directs agencies to assess all costs and benefits of available 
regulatory alternatives and, if regulation is necessary, to select 
regulatory approaches that maximize net benefits (including potential 
economic, environmental, public health and safety effects; distributive 
impacts; and equity). E.O. 13563 is supplemental to and reaffirms the 
principles, structures, and definitions governing regulatory review as 
established in E.O. 12866. OMB's Office of Information and Regulatory 
Affairs (OIRA) has determined that this direct final rule is not a 
significant regulatory action as defined by E.O. 12866, section 3(f).

Analysis of Benefits and Costs

    DEA has analyzed the economic impact of this direct final rule and 
estimates the annual cost to be $0. This rule is minor and technical in 
nature, merely clarifying existing DEA regulations and requirements. 
Current regulations require the supplier's DEA registration number to 
be entered on the single-sheet DEA Form 222. Thus, this rule does not 
impose any new requirement and there is no new cost or labor burden 
associated with this rule.
    While this direct final rule will result in no economic impact on 
registrants or DEA, DEA believes there are certain benefits of this 
rule. This rule is expected to enhance clarity as well as flexibility, 
by clearly stating that either the purchaser or the supplier may enter 
the supplier's DEA registration number on the DEA Form 222. While DEA 
does not have a basis to quantify the benefits, DEA believes the 
benefits are real and welcomed by the affected registrants.

Executive Order 12988, Civil Justice Reform

    This direct final rule meets the applicable standards set forth in 
sections 3(a) and 3(b)(2) of E.O. 12988 to eliminate drafting errors 
and ambiguity, minimize litigation, provide a clear legal standard for 
affected conduct, and promote simplification and burden reduction.

Executive Order 13132, Federalism

    This direct final rule does not have federalism implications 
warranting the application of E.O. 13132. The direct final rule does 
not have substantial direct effects on the States, on the relationship 
between the national government and the States, or on the distribution 
of power and responsibilities among the various levels of government.

Executive Order 13175, Consultation and Coordination With Indian Tribal 
Governments

    This direct final rule does not have tribal implications warranting 
the application of E.O. 13175. It does not have substantial direct 
effects on one or more Indian tribes, on the relationship between the 
Federal government and Indian tribes, or on the distribution of power 
and responsibilities between the Federal government and Indian tribes.

Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) applies to 
rules that are subject to notice and comment under section 553(b) of 
the APA or other laws. As explained above, DEA determined that there is 
good cause to exempt this direct final rule from notice and comment. 
Consequently, the RFA does not apply to this direct final rule.

Unfunded Mandates Reform Act of 1995

    In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995, 
2 U.S.C. 1501 et seq., DEA has determined that this action would not 
result in any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100 million or more (adjusted annually for 
inflation) in any one year. Therefore, neither a Small Government 
Agency Plan nor any other action is required under UMRA of 1995.

[[Page 38232]]

Paperwork Reduction Act of 1995

    This direct final rule does not impose a new collection requirement 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). This 
direct final rule does not impose new recordkeeping or reporting 
requirements on State or local governments, individuals, businesses, or 
organizations. Although the direct final rule is applicable to an 
existing collection of information, the rule merely clarifies certain 
recordkeeping requirements that already apply to registrants using DEA 
Form 222 and therefore does not impose any new collection of 
information requirement. An agency may not conduct or sponsor, and a 
person is not required to respond to, a collection of information 
unless it displays a currently valid OMB control number.

Congressional Review Act

    OIRA has determined that this direct final rule is not a major rule 
as defined by Subtitle E of the Small Business Regulatory Enforcement 
Fairness Act of 1996 (known as the Congressional Review Act or CRA), 5 
U.S.C. 804(2). This direct final rule will not result in an annual 
effect on the economy of $100 million or more; a major increase in 
costs or prices; or significant adverse effects on competition, 
employment, investment, productivity, innovation, or the ability of 
United States-based companies to compete with foreign-based companies 
in domestic and export markets. However, pursuant to the CRA, DEA is 
submitting a copy of this direct final rule to both Houses of Congress 
and to the Comptroller General.

List of Subjects

21 CFR Part 1305

    Drug traffic control, Reporting and recordkeeping requirements.

    For the reasons set out above, DEA amends 21 CFR part 1305 as 
follows:

PART 1305--ORDERS FOR SCHEDULE I AND II CONTROLLED SUBSTANCES

0
1. The authority citation for part 1305 continues to read as follows:

    Authority:  21 U.S.C. 821, 828, 871(b), unless otherwise noted.


0
2. In Sec.  1305.12, add a sentence to the end of paragraph (c) to read 
as follows:


Sec.  1305.12  Procedure for executing DEA Forms 222.

* * * * *
    (c) * * * The supplier's DEA registration number may be entered by 
the purchaser or the supplier.
* * * * *

0
3. In Sec.  1305.13, revise the first sentence of paragraph (b) to read 
as follows:


Sec.  1305.13  Procedure for filling DEA Forms 222.

* * * * *
    (b) A supplier may fill the order, if possible and if the supplier 
desires to do so, and must record on the original DEA Form 222 its DEA 
registration number (if not previously entered by the purchaser) and 
the number of commercial or bulk containers furnished on each item and 
the date on which containers are shipped to the purchaser. * * *
* * * * *

Anne Milgram,
Administrator.
[FR Doc. 2021-15323 Filed 7-19-21; 8:45 am]
BILLING CODE 4410-09-P